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Approximately 340 participants (680 eyes) will be enrolled in this three-month, two-arm, 1:1 randomized, parallel-group, bilateral, double-masked study at approximately 22 investigative sites in the United States. Participants will be required to wear dispensed study lenses on a daily wear basis for three months with scheduled in-office replacement of study lenses at the 1-Month and 2-Month Follow-Up Visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BL-3100-NBR03 | Experimental | BL-3100-NBR03 multi-purpose solution |
|
| renu® Advanced Formula | Active Comparator | renu® Advanced Formula multi-purpose solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BL-3100-NBR03 multi-purpose solution | Device | BL-3100-NBR03 multi-purpose solution used to clean and disinfect contact lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Comfort Averaged Over All Follow-up Visits | Overall comfort will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response | Assessed at all follow-up visits through 3 months. |
| Vision Averaged Over All Follow-up Visits | Vision will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response | Assessed at all follow-up visits through 3 months. |
| The Proportion of Eyes With a Maximum Degree of Front Surface Deposits Grade of <= 2 Over All Follow-up Visits With 0 Being Absent of Deposits. | The degree of front surface deposits will be graded for each eye as: 0 - Absent, clean surface.
| Assessed at all follow-up visits through 3 months. |
| The Proportion of Eyes With Any Slit-lamp Findings Greater Than Grade 2 Over All Follow-up Visits. | Graded slit-lamp findings will be assessed for each eye using Grades 0 through 4. | Assessed at 3 months |
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Inclusion Criteria:
Exclusion Criteria:
Is currently using a hydrogen-peroxide cleaning and disinfecting solution
Participated in any drug or device clinical investigation within 30 days prior to entry into this study
Is a female of childbearing potential (those who are not surgically sterilized or postmenopausal) if they meet any one of the following conditions:
Has worn gas permeable (GP) lenses within the last 30 days
Has worn polymethylmethacrylate (PMMA) lenses within the last three months
Has typically worn their pre-study contact lenses on an extended wear basis, sleeping in their lenses one night or more per week, during the last year
Has any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study
Subjects with an active ocular disease, or who are using any ocular medication.
Is using any medications that will, in the Investigator's opinion, affect ocular physiology or lens performance
Currently wears monovision, multifocal, or toric contact lenses
Has ocular astigmatism of 1.00D or greater in either eye
Has anisometropia (spherical equivalent) of greater than 2.00D
Has any grade 2 or greater finding during the slit-lamp examination (refer to Appendix B for Methods of Clinical Evaluation)
Has corneal infiltrates, of ANY GRADE
Has any "Present" ungraded finding during the slit-lamp examination (refer to Appendix B for Methods of Clinical Evaluation) that, in the Investigator's judgment, interferes with contact lens wear.
Has typically worn their pr-study control lenses on an extended wear bases, sleeping on their lenses one night or more per week, during the last year.
Is aphakic
Is amblyopic
Has had any corneal surgery (e.g., refractive surgery)
Is allergic to any component in the study care products.
Is an employee of any of the study investigative sites or a family member of an employee of the investigative site, including family members living outside of the employee's household
Is an Ophthalmologist, an Optometrist, an Optician, or an Ophthalmic Assistant/Technician, or currently resides with a person with any of these specialties
Is an employee of a manufacturer of contact lenses or contact lens care products (e.g., Alcon, Bausch + Lomb, Ciba Vision, CooperVision, Vistakon, Johnson & Johnson, etc.) or currently resides with a person employed by any of these manufacturers.
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Donatello | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eric White OD Inc | San Diego | California | 92123 | United States | ||
| Lee & Woo Optometry |
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| ID | Title | Description |
|---|---|---|
| FG000 | BL-3100-NBR03 | BL-3100-NBR03 multi-purpose solution BL-3100-NBR03 multi-purpose solution: BL-3100-NBR03 multi-purpose solution used to clean and disinfect contact lenses |
| FG001 | Renu® Advanced Formula |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 19, 2023 | Feb 3, 2025 |
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| renu® Advanced Formula multi-purpose solution | Device | renu® Advanced Formula multi-purpose solution used to clean and disinfect contact lenses |
|
| San Francisco |
| California |
| 94112 |
| United States |
| Chester T Roe III MD Prof LLC | Denver | Colorado | 80246 | United States |
| Eola Eyes | Orlando | Florida | 32803 | United States |
| Golden Vision | Sarasota | Florida | 34237 | United States |
| The Eyecare Studio, LLC | Decatur | Georgia | 30035 | United States |
| Kannarr EyeCare | Pittsburg | Kansas | 66762 | United States |
| Casco Bay EyeCare | Portland | Maine | 04101 | United States |
| Complete Eye Care of Medina | Medina | Minnesota | 55340 | United States |
| Advanced Eye Care, PC | Raytown | Missouri | 64133 | United States |
| Koetting Associates | St Louis | Missouri | 63144 | United States |
| InSight Eyecare | Warrensburg | Missouri | 64093 | United States |
| Berlin Eyecare Associates | West Berlin | New Jersey | 08091 | United States |
| Spectrum Eyecare | Jamestown | New York | 14701 | United States |
| Saccco Eye Group | Vestal | New York | 13850 | United States |
| Oculus Research | Raleigh | North Carolina | 27603 | United States |
| Total Eye Care, PA | Memphis | Tennessee | 38119 | United States |
| Optometric Physicians of Middle Tennessee | Nashville | Tennessee | 37205 | United States |
| Biopharma Informatic | Houston | Texas | 77043 | United States |
renu® Advanced Formula multi-purpose solution
renu® Advanced Formula multi-purpose solution: renu® Advanced Formula multi-purpose solution used to clean and disinfect contact lenses
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BL-3100-NBR03 | BL-3100-NBR03 multi-purpose solution BL-3100-NBR03 multi-purpose solution: BL-3100-NBR03 multi-purpose solution used to clean and disinfect contact lenses |
| BG001 | Renu® Advanced Formula | renu® Advanced Formula multi-purpose solution renu® Advanced Formula multi-purpose solution: renu® Advanced Formula multi-purpose solution used to clean and disinfect contact lenses |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Comfort Averaged Over All Follow-up Visits | Overall comfort will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response | Posted | Mean | Standard Deviation | score on a scale | Assessed at all follow-up visits through 3 months. | Eyes | Eyes |
|
|
| |||||||||||||||||||||||||||||
| Primary | Vision Averaged Over All Follow-up Visits | Vision will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response | Posted | Mean | Standard Deviation | score on a scale | Assessed at all follow-up visits through 3 months. | Eyes | Eyes |
|
| ||||||||||||||||||||||||||||||
| Primary | The Proportion of Eyes With a Maximum Degree of Front Surface Deposits Grade of <= 2 Over All Follow-up Visits With 0 Being Absent of Deposits. | The degree of front surface deposits will be graded for each eye as: 0 - Absent, clean surface.
| All randomized subjects with at least one non-missing values for front surface deposit grading. Two subjects (4 eyes) in the BL-3100-NBR03 arm and 1 subject (2 eyes) in the renu Advanced Formula arm with no front surface grading measurements reported were excluded from this analysis. | Posted | Number | percentage of eyes | Assessed at all follow-up visits through 3 months. | Eyes | Eyes |
| |||||||||||||||||||||||||||||||
| Primary | The Proportion of Eyes With Any Slit-lamp Findings Greater Than Grade 2 Over All Follow-up Visits. | Graded slit-lamp findings will be assessed for each eye using Grades 0 through 4. | Posted | Number | percentage of eyes | Assessed at 3 months | Eyes | Eyes |
|
|
AE data collected over all scheduled follow-up visits approximately 3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BL-3100-NBR03 | BL-3100-NBR03 multi-purpose solution BL-3100-NBR03 multi-purpose solution: BL-3100-NBR03 multi-purpose solution used to clean and disinfect contact lenses | 0 | 143 | 0 | 143 | 0 | 143 |
| EG001 | Renu® Advanced Formula | renu® Advanced Formula multi-purpose solution renu® Advanced Formula multi-purpose solution: renu® Advanced Formula multi-purpose solution used to clean and disinfect contact lenses | 0 | 151 | 1 | 151 | 0 | 151 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA Version 25.1 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Donatello | Bausch & Lomb | 5853385306 | Daniel.Donatello@bausch.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 11, 2024 | Feb 3, 2025 | SAP_001.pdf |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Eyes |
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| Units | Counts |
|---|
| Participants |
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| Eyes |
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| Eyes |
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